Frequent Users of the Emergency DepartmentNCT01934322
Case Management for Frequent Users of the Emergency Department
A study testing Case Management in people with Frequent Users of the Emergency Department and Vulnerable Populations, run by University of Lausanne at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate a specific case management intervention for frequent users (FU) of Emergency Department (ED). Compared to infrequent or non-users, most of the ED-FU visitors are identified as vulnerable patients because they are more likely to be of low social and economical status, be more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frequent Users of the Emergency Department, Vulnerable Populations
- What is being tested?
- Case Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 5 or more attendances during the previous 12 months at the Emergency Department of the University Hospital of Lausanne
- Be capable of communicating in any of the languages spoken by the team (i.e. French, English, German, Italian and Spanish) or through a community interpreter
Who cannot join
- Patients who cannot give informed consent or are ineligible to receive Case Managers services (e.g. acutely confused, acutely psychotic, intoxicated)
- Patients who are in prison
- Patients with a diagnose of cognitive disorders (delirium, dementia, and other cognitive disorders)
- Patients who are not expected to survive at least 18 months after enrollment
- Patients who will not remain in Switzerland for 12 to 18 months after enrollment
- Family members of a participant already included
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case Management for Frequent Users of the Emergency Department: A Randomized Controlled Trial
The purpose of this study is to evaluate a specific case management intervention for frequent users (FU) of Emergency Department (ED).
Compared to infrequent or non-users, most of the ED-FU visitors are identified as vulnerable patients because they are more likely to be of low social and economical status, be more isolated and live alone. They report more chronic medical conditions, have a higher mortality rate and consume more healthcare resources.
Read more
In the literature, interventions aimed at improving the management of ED-FU have demonstrated several positive outcomes, but there are still some knowledge gaps.
The proposed project tests the hypotheses that case management intervention as compared with standard emergency care
- is a more efficient use of healthcare resources and reduces ED attendance,
- is cost-saving and
- improves quality of life,
- altogether leading to favorable cost-utility ratio.
- Being tested
- Case Management
- Keywords
- frequent users of the emergency department, vulnerable populations, case management, cost savings intervention, quality of life, number of emergency department visits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case ManagementOther
Furnish specific assistance and to provide referrals for the patients:
- If the social determinants are not adequate, the team will lend assistance for obtaining income entitlements, health insurance coverage if eligible, stable housing, schooling for children, etc.
- If there are mental disturbances, the team will refer to mental health departments inside the hospital, and if necessary, to a psychiatrist, psychologist or general practitioner (GP) out in the community.
- If the patient presents risk behaviors, the team will refer to substance abuse services and links to community services in order to maintain continuity of care.
- In case of somatic problems, the team will find a new GP or make contact with the previous provider, contingent on the patient's consent.
| Study group | Role | What they receive |
|---|---|---|
| Case Management | Experimental | Furnish specific assistance and to provide referrals for the patients:
* If the social determinants are not adequate, the team will lend assistance for obtaining income entitlements, health insurance coverage if eligible, stable housing, schooling for children, etc.
* If there are mental disturbances, the team will refer to mental health departments inside the hospital, and if necessary, to a psychiatrist, psychologist or general practitioner (GP) out in the community.
* If the patient presents risk behaviors, the team will refer to substance abuse services and links to community services in order to maintain continuity of care.
* In case of somatic problems, the team will find a new GP or make contact with the previous provider, contingent on the patient's consent. Receives: Other: Case Management |
| Control | No intervention | Patients randomized to control group (usual care) will receive standard emergency care by physicians (resident or attending physician) and nurses, without the case manager been involved. Nevertheless, the mobile team will take contact with each patient of the control group, giving them short information through a flyer (flyer) which will underline the existence of the mobile team, its addresses and telephone numbers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of Emergency Department visits
Measured: 12 months after enrollement
Secondary outcomes (1)
total costs of the healthcare resource
costs concerning services provided by the University Hospital of Lausanne and cost concerning services used outside the Hospital
Measured: 12 months after enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startJun 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Frequent Users of the Emergency DepartmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Patrick Bodenmann, University of Lausanne
- Investigators
- Bodenmann Patrick, PD, MER, MSc, Principal investigator, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934322
- Sponsor's protocol ID
- FNS 30023B_135762/1
- Status last verified
- May 2015
- First submitted
- 29 Aug 2013
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Althaus F, Paroz S, Hugli O, Ghali WA, Daeppen JB, Peytremann-Bridevaux I, Bodenmann P. Effectiveness of interventions targeting frequent users of emergency departments: a systematic review. Ann Emerg Med. 2011 Jul;58(1):41-52.e42. doi: 10.1016/j.annemergmed.2011.03.007.
PubMed 21689565Bieler G, Paroz S, Faouzi M, Trueb L, Vaucher P, Althaus F, Daeppen JB, Bodenmann P. Social and medical vulnerability factors of emergency department frequent users in a universal health insurance system. Acad Emerg Med. 2012 Jan;19(1):63-8. doi: 10.1111/j.1553-2712.2011.01246.x. Epub 2012 Jan 5.
PubMed 22221292Althaus F, Stucki S, Guyot S, Trueb L, Moschetti K, Daeppen JB, Bodenmann P. Characteristics of highly frequent users of a Swiss academic emergency department: a retrospective consecutive case series. Eur J Emerg Med. 2013 Dec;20(6):413-9. doi: 10.1097/MEJ.0b013e32835e078e.
PubMed 23337095Shumway M, Boccellari A, O'Brien K, Okin RL. Cost-effectiveness of clinical case management for ED frequent users: results of a randomized trial. Am J Emerg Med. 2008 Feb;26(2):155-64. doi: 10.1016/j.ajem.2007.04.021.
PubMed 18272094Iglesias K, Baggio S, Moschetti K, Wasserfallen JB, Hugli O, Daeppen JB, Burnand B, Bodenmann P. Using case management in a universal health coverage system to improve quality of life of frequent Emergency Department users: a randomized controlled trial. Qual Life Res. 2018 Feb;27(2):503-513. doi: 10.1007/s11136-017-1739-6. Epub 2017 Nov 29.
PubMed 29188481Bodenmann P, Velonaki VS, Ruggeri O, Hugli O, Burnand B, Wasserfallen JB, Moschetti K, Iglesias K, Baggio S, Daeppen JB. Case management for frequent users of the emergency department: study protocol of a randomised controlled trial. BMC Health Serv Res. 2014 Jun 17;14:264. doi: 10.1186/1472-6963-14-264.
PubMed 24938769
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Management for Frequent Users of the Emergency Department: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01934322
- Acronym / sponsor ID
- FNS 30023B_135762/1
- Keywords
- frequent users of the emergency department, vulnerable populations, case management, cost savings intervention, quality of life, number of emergency department visits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate a specific case management intervention for frequent users (FU) of Emergency Department (ED).
Compared to infrequent or non-users, most of the ED-FU visitors are identified as vulnerable patients because they are more likely to be of low social and economical status, be more isolated and live alone. They report more chronic medical conditions, have a higher mortality rate and consume more healthcare resources.
In the literature, interventions aimed at improving the management of ED-FU have demonstrated several positive outcomes, but there are still some knowledge gaps.
The proposed project tests the hypotheses that case management intervention as compared with standard emergency care
- is a more efficient use of healthcare resources and reduces ED attendance,
- is cost-saving and
- improves quality of life,
- altogether leading to favorable cost-utility ratio.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Management | Experimental | Other: Case ManagementFurnish specific assistance and to provide referrals for the patients: * If the social determinants are not adequate, the team will lend assistance for obtaining income entitlements, health insurance coverage if eligible, stable housing, schooling for children, etc. * If there are mental disturbances, the team will refer to mental health departments inside the hospital, and if necessary, to a psychiatrist, psychologist or general practitioner (GP) out in the community. * If the patient presents risk behaviors, the team will refer to substance abuse services and links to community services in order to maintain continuity of care. * In case of somatic problems, the team will find a new GP or make contact with the previous provider, contingent on the patient's consent. |
| Control | No intervention | –Patients randomized to control group (usual care) will receive standard emergency care by physicians (resident or attending physician) and nurses, without the case manager been involved. Nevertheless, the mobile team will take contact with each patient of the control group, giving them short information through a flyer (flyer) which will underline the existence of the mobile team, its addresses and telephone numbers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 5 or more attendances during the previous 12 months at the Emergency Department of the University Hospital of Lausanne
- Be capable of communicating in any of the languages spoken by the team (i.e. French, English, German, Italian and Spanish) or through a community interpreter
Key exclusion criteria (6 listed)
- Patients who cannot give informed consent or are ineligible to receive Case Managers services (e.g. acutely confused, acutely psychotic, intoxicated)
- Patients who are in prison
- Patients with a diagnose of cognitive disorders (delirium, dementia, and other cognitive disorders)
- Patients who are not expected to survive at least 18 months after enrollment
- Patients who will not remain in Switzerland for 12 to 18 months after enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case ManagementFurnish specific assistance and to provide referrals for the patients: * If the social determinants are not adequate, the team will lend assistance for obtaining income entitlements, health insurance coverage if eligible, stable housing, schooling for children, etc. * If there are mental disturbances, the team will refer to mental health departments inside the hospital, and if necessary, to a psychiatrist, psychologist or general practitioner (GP) out in the community. * If the patient presents risk behaviors, the team will refer to substance abuse services and links to community services in order to maintain continuity of care. * In case of somatic problems, the team will find a new GP or make contact with the previous provider, contingent on the patient's consent. | Other | Case Management |
Primary outcome
number of Emergency Department visits
Time frame: 12 months after enrollement
1 secondary outcome
total costs of the healthcare resource
Time frame: 12 months after enrollement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Background: PubMed 21689565Althaus F, Paroz S, Hugli O, Ghali WA, Daeppen JB, Peytremann-Bridevaux I, Bodenmann P. Effectiveness of interventions targeting frequent users of emergency departments: a systematic review. Ann Emerg Med. 2011 Jul;58(1):41-52.e42. doi: 10.1016/j.annemergmed.2011.03.007.
- Background: PubMed 22221292Bieler G, Paroz S, Faouzi M, Trueb L, Vaucher P, Althaus F, Daeppen JB, Bodenmann P. Social and medical vulnerability factors of emergency department frequent users in a universal health insurance system. Acad Emerg Med. 2012 Jan;19(1):63-8. doi: 10.1111/j.1553-2712.2011.01246.x. Epub 2012 Jan 5.
- Background: PubMed 23337095Althaus F, Stucki S, Guyot S, Trueb L, Moschetti K, Daeppen JB, Bodenmann P. Characteristics of highly frequent users of a Swiss academic emergency department: a retrospective consecutive case series. Eur J Emerg Med. 2013 Dec;20(6):413-9. doi: 10.1097/MEJ.0b013e32835e078e.
- Background: PubMed 18272094Shumway M, Boccellari A, O'Brien K, Okin RL. Cost-effectiveness of clinical case management for ED frequent users: results of a randomized trial. Am J Emerg Med. 2008 Feb;26(2):155-64. doi: 10.1016/j.ajem.2007.04.021.
- Derived from this study: PubMed 29188481Iglesias K, Baggio S, Moschetti K, Wasserfallen JB, Hugli O, Daeppen JB, Burnand B, Bodenmann P. Using case management in a universal health coverage system to improve quality of life of frequent Emergency Department users: a randomized controlled trial. Qual Life Res. 2018 Feb;27(2):503-513. doi: 10.1007/s11136-017-1739-6. Epub 2017 Nov 29.
- Derived from this study: PubMed 24938769Bodenmann P, Velonaki VS, Ruggeri O, Hugli O, Burnand B, Wasserfallen JB, Moschetti K, Iglesias K, Baggio S, Daeppen JB. Case management for frequent users of the emergency department: study protocol of a randomised controlled trial. BMC Health Serv Res. 2014 Jun 17;14:264. doi: 10.1186/1472-6963-14-264.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bodenmann Patrick, PD, MER, MSc principal investigator
University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case Management in people with Frequent Users of the Emergency Department and Vulnerable Populations, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of Emergency Department visits (time frame: 12 months after enrollement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01934322, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.